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OpenTrials
Completed

NCT Number: NCT03679949

Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia

The purpose of this research is to assess the impact of cannabis on the analgesic and abuse-liability effects of a sub-threshold dose of a commonly used analgesic.

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Key information

Conditions

Pain Abuse, Drug Chemically-Induced Disorders Marijuana Abuse Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders

Age range

21 year–53 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New York State Psychiatric Institute

New York, 10032, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or non-pregnant female aged 21-53 years
  • Previous cannabis use
  • Previous opioid use
  • Urine test positive for recent cannabis use
  • Being able to perform all study procedures
  • Currently practicing an effective form of birth control (women only)

Exclusion criteria

  • Meeting criteria for some Use Disorders
  • Report regular illicit drug use
  • If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process revealed any significant illness

Treatment and study plan

Oxycodone

Drug

Oxycodone, 2.5 mg

Cannabis (THC:CBD = ~ 1:0)

Drug

Cannabis with high THC concentration and negligible CBD concentrations

Cannabis (THC:CBD = ~ 0:1)

Drug

Cannabis with high CBD concentration and negligible THC concentrations

Cannabis (THC:CBD = ~ 1:1)

Drug

Cannabis with equivalent CBD and THC concentrations

Placebo

Drug

Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone

Other names: Placebo cannabis

Primary outcomes

  1. Subjective Effects

    Time frame: 6 weeks

    Participants will rate "drug liking", "good drug effects", and "high" on a visual analogue scale (VAS; 1-100mm).

  2. Cold Pressor Test

    Time frame: 6 weeks

    Participants will immerse their hand in a bucket of ice water to determine pain threshold and pain tolerance latencies (in seconds).

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 21, 2018
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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